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The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

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I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text is a 510(k) clearance letter for the Allura™ Vaginal Stent and does not contain information about acceptance criteria or supporting studies. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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The Platinum Depthalon® Depth Electrodes are intended for temporary (

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "PMT Platinum Depthalon Depth Electrodes". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation number.
• The indication for use of the device.
• General controls provisions and other compliance requirements for the manufacturer.
• Contact information for FDA divisions.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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